Sr. Validation Specialist, Quality Assurance
Reporting to the Sr. Director Quality Assurance, this person will be responsible for cGMP compliance of process, facility, utilities, equipment, method and computer system validation and will be accountable for their execution across the Moderna drug development ecosystem. The role is responsible for ensuring review and approval of all validation records and documentation (i.e. process validation, cleaning validation, computer system validation, method validation/transfer, and equipment lifecycle documentation) are compliant with in-house specifications/standards/procedures and Good Manufacturing Practices.
- Provide QA oversight of commissioning, qualification and validation activities to deliver Moderna's new early phase GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods and personalized medicine capabilities.
- Responsible for managing the review/approval of design and commissioning documentation, validation protocols, reports and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues.
- Reviews and assists in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods and laboratory instruments.
- Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method and computer system validation.
- Leads and/or participates in multi-functional department teams for validated process, equipment, utilities, method and computer systems, to meet established timeframe for project implementations that support business needs and meet global regulatory requirements.
- Responsible for supporting internal and external inspections as a Subject Matter Expert for Quality Assurance Validation.
- Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
- Oversight of contractors/consultants in performing similar tasks supporting large projects, including ensuring adequate qualifications and training, oversight/review of their effort, and management of their priorities and work product.
- Bachelor's degree in a scientific or health-related field required.
- Minimum of 5 years of Validation experience in the biotechnology or pharmaceutical industries required.
- Experience in IT systems, automation, operations and manufacturing within the biotechnology industry and in new manufacturing facility startup environments is a plus.
- Demonstrated strong ability in problem solving, strong understanding of cGMPs, excellent interpersonal skills and the ability to prioritize multiple tasks. Uses a team-oriented approach to project management and problem resolution.
- Excellent understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations. Ability to interact effectively with all levels of personnel within the organization.
- Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate.
- Proven ability to manage projects while meeting all deliverables and timelines.
- Strong knowledge of global regulatory requirements for validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11.
- Demonstrate strong organizational skills, building relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail.
- Practical experience with Quality by Design is a plus.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.